TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

NCT03860038 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2025-04-24

No results posted yet for this study

Summary

This trial is a multi-center, single-arm phase 2 study to evaluate the efficacy and safety of TJ202 combined with dexamethasone in subjects with relapsed or refractory multiple myeloma (RRMM) who received at least 2 prior lines of treatment.

Conditions

  • Multiple Myeloma in Relapse
  • Refractory Multiple Myeloma

Interventions

DRUG

TJ202 and Dexamethasone

one dose of TJ202 16 mg/kg or an adjusted dose will be administered on Day 1 and Day 4 of Week 1, then every week from Week 2 to Week 12, then every 2 weeks from Week 13 to Week 24 and then every 4 weeks thereafter, until the subjects experience an onset of endpoint events like intolerance or PD. DEX 40 mg will be administered on Day 1 and Day 4 of Week 1, respectively and then 40mg weekly thereafter.

Sponsors & Collaborators

  • TJ Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lugui Qiu, Doctor · Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2023-01-28
Completion
2023-01-28

Countries

  • China
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03860038 on ClinicalTrials.gov